Category
FDA recalls of prescription and over-the-counter drugs.
FDA drug recalls cover prescription medicines, over-the-counter products, biologic and gene therapies, and active pharmaceutical ingredients (the raw drug substances that manufacturers compound into finished products). Recall classifications follow the same Class I / II / III system as food, and most published recalls are Class II — the product is unlikely to cause permanent harm but doesn't meet specification.
The most common reasons for a drug recall are out-of-specification potency or dissolution (the active ingredient is present in too high or too low a dose), microbial contamination, particulate matter in injectables, mix-ups during packaging where bottles end up with the wrong tablets, and nitrosamine impurities in certain drug classes. Many drug recalls are at the lot level — the manufacturer's whole product line is still safe to use, but specific production lots are pulled.
If a recall affects your medication: don't stop taking it on your own. Call your prescriber or pharmacist before doing anything. Stopping a prescribed drug abruptly can be more dangerous than the issue prompting the recall. Most drug-recall remedies route through the dispensing pharmacy, who'll either swap your supply for an unaffected lot or coordinate a refund with the manufacturer.
Dr. Reddy's Laboratories is recalling specific lots of Lansoprazole 15 mg delayed-release capsules nationwide because the capsules failed to dissolve properly during long-term stability testing, which could affect medication effectiveness.
Aurolife Pharma is recalling Glycopyrrolate Tablets after glass fragments were discovered in a sealed bottle from packaging equipment. Approximately 4,080 bottles were distributed nationwide and in Puerto Rico.
Drug Depot recalls 1,843 vials of Gonadorelin injectable nationwide due to lack of sterility assurance. Patients should consult their healthcare provider regarding previously dispensed doses.
Drug Depot, Inc. is recalling 24 vials of Testosterone Cypionate 200 MG/ML Injectable nationwide due to lack of sterility assurance. The product was distributed throughout the USA and Puerto Rico.
Drug Depot, Inc. is recalling 620 vials of Testosterone Cypionate/DHEA injectables due to lack of sterility assurance in manufacturing. The product was distributed nationwide.
Drug Depot, Inc. is recalling Gonadorelin 0.2 mg/mL injectable vials distributed nationwide due to lack of sterility assurance. Approximately 6,017 vials are affected.
Dr. Reddy's Laboratories is recalling 28,068 bottles of Atorvastatin Calcium 80 mg tablets nationwide due to failed impurity and degradation specifications. No illnesses or injuries have been reported.
Dr. Reddy's Laboratories is recalling 7,703 bottles of Lansoprazole Delayed-Release Capsules (30 mg, 90-count) nationwide due to failed dissolution specifications found during long-term stability testing.
Taro Pharmaceuticals recalls Clotrimazole and Betamethasone Dipropionate cream after a stability sample failed potency testing. The recall affects 768 tubes distributed to a retailer in New York, expiring June 2023. No illnesses have been reported.
Fresenius Kabi USA is recalling sodium acetate injection due to the presence of particulate matter composed of carbon, oxygen, iron, and trace elements in multiple lots distributed nationwide.
The FDA has recalled Revitaderm Wound Care gel (Benzalkonium Chloride 0.1%) distributed nationwide due to contamination with Bacillus cereus. The affected product was distributed to 45 doctors in 17 states.
Olympia Compounding Pharmacy is recalling Sincalide lyophilized powder for injection due to concerns about super potency and failed reconstitution time. The product is distributed nationwide, including Puerto Rico.
Tennessee Technical Coatings Corporation is recalling one lot of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% (1 U.S. Gallon) due to FDA analysis finding methanol contamination. The product was distributed in Alabama and Tennessee.
Tennessee Technical Coatings is recalling hand sanitizer products due to CGMP deviations. Certain lots were manufactured under the same conditions as a product lot found to contain methanol.
Athenex Pharma Solutions is recalling Norepinephrine Bitartrate Injection due to defective containers affecting specific lots distributed nationwide.
Akorn, Inc. is recalling 62,331 boxes of TheraTears Extra lubricant eye drops distributed nationwide due to lack of assured sterility. Non-sterile eye drops could pose infection risks.
Olympia Compounding Pharmacy is recalling NAD+ Nicotinamide Adenine Dinucleotide injection vials nationwide due to sub-potency or exceeded reconstitution time.
Teligent Pharma is recalling Betamethasone Dipropionate Lotion due to manufacturing practice deviations and discontinuation of the stability study program. The recall affects 43,218 bottles distributed nationwide.
Teligent Pharma, Inc. is recalling Fluocinonide Cream USP 0.1% due to manufacturing compliance deviations and discontinuation of stability studies. The recall affects products nationwide in the USA and Puerto Rico.
Teligent Pharma is recalling all unexpired Diflorasone Diacetate Ointment 0.05% due to cGMP deviations. The company discontinued its stability study program, preventing verification that the product maintains safety and effectiveness throughout shelf life.
Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.5% due to current good manufacturing practice (cGMP) deviations. The firm has discontinued its stability study program, affecting approximately 159,994 tubes distributed nationwide.
Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.1% nationwide because the manufacturer is discontinuing its stability study program, creating a current Good Manufacturing Practice (cGMP) deviation.
Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Ointment USP 0.05% nationwide because the manufacturer is discontinuing its stability study program, raising questions about product integrity.
Athenex Pharma Solutions is recalling Norepinephrine Bitartrate Injection 8 mg per 250 mL due to a defective container. The recall affects approximately 9,800 bags distributed nationwide.
Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Gel 0.05% due to deviations from good manufacturing practices. The firm discontinued its stability study program, prompting the recall of 81,883 tubes distributed nationwide and in Puerto Rico.
Looking for a different category? Browse all recalls.